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FDA 510(k)

STAT K IN VITRO DIAGNOSTIC TEST SYSTEM

K-Number: K042270 · 2004-10-06

ApplicantStat Chem, Inc.
Decision Date2004-10-06
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT K IN VITRO DIAGNOSTIC TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stat Chem, Inc.. It received FDA 510(k) clearance on 2004-10-06 under 510(k) number K042270. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT K IN VITRO DIAGNOSTIC TEST SYSTEM?

STAT K IN VITRO DIAGNOSTIC TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-06. The listed applicant is Stat Chem, Inc.. The 510(k) number is K042270.

When did STAT K IN VITRO DIAGNOSTIC TEST SYSTEM receive FDA 510(k) clearance?

STAT K IN VITRO DIAGNOSTIC TEST SYSTEM received FDA 510(k) clearance on 2004-10-06, under 510(k) number K042270.

Who is the listed applicant for STAT K IN VITRO DIAGNOSTIC TEST SYSTEM?

The FDA 510(k) record lists Stat Chem, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAT K IN VITRO DIAGNOSTIC TEST SYSTEM?

The FDA product code for STAT K IN VITRO DIAGNOSTIC TEST SYSTEM is CEM.

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Related Devices (Code: CEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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